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Feasibility of Telerehabilitation in HIV-patients

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endurance ad Resistance Training Exercise
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • under HAART treatment
  • native French speaker

Exclusion Criteria:

  • AIDS diagnosis
  • physical and/or psychiatric impairments that seriously impaired physical activity
  • pregnant
  • Unstable (defined by any modification of health outcomes during the last 6 months).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Endurance and Resistance Training Exercise

    Control group

    Arm Description

    Usual care

    Outcomes

    Primary Outcome Measures

    Recruitment rate
    Number of eligible participants who enrolled in the program out of the number were recruited
    Retention rate
    Percentage of patients lost to follow-up
    Adverse events
    Percentage of patients who experienced one or more adverse events

    Secondary Outcome Measures

    Weight
    Weight (kg) is measured by using a bioelectrical impedance analysis
    Lean body mass
    Lean body mass (kg) is measured by using a bioelectrical impedance analysis
    Fat body mass
    Lean body mass (kg) is measured by using a bioelectrical impedance analysis
    C-reactive protein
    C-reactive protein is measured by a blood test
    D-dimer
    D-dimer is measured by a blood test
    CD4+ T cell counts
    CD4+ T cell counts is measured by a blood test
    Viral load
    Viral load is measured by a blood test
    Functional exercise capacity
    Functional exercise capacity is measured by a 6-minute walk test
    Flexibility
    Flexibility is measured by Toe touch test and sit and reach test
    Lower body muscular strength
    Lower body muscular strength is measured by 30-s chair-stand test
    Upper limb strength
    Upper limb strength is measured by hand grip strength tool
    Quality of life
    Quality of life is measured by World Health Organization Quality of Life HIV Instrument

    Full Information

    First Posted
    October 31, 2017
    Last Updated
    November 2, 2017
    Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03335176
    Brief Title
    Feasibility of Telerehabilitation in HIV-patients
    Official Title
    Feasibility and Benefit of a Telerehabilitation Program in Human Immunodeficiency Virus-infected Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2014 (Actual)
    Primary Completion Date
    April 1, 2015 (Actual)
    Study Completion Date
    April 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to assess the feasibility and the effects of a 6-week telerehabilitation on the three domains of the International Classification of Functioning, Disability and Health in HIV-infected patients under highly active antiretroviral therapy (HAART). HIV-infected patients were randomized either into an Endurance and Resistance Training Exercise (ERTE) group or a control (CON) group. Telerehabilitation was realized in a public fitness center, with online guidance and weekly telephone advice, 3 times per week for 6 weeks. Feasibility was determined by recruitment rate, retention rate and adverse events. Secondary outcomes were impact on body composition, inflammation and coagulation (C-reactive protein, D-dimer), physical fitness and quality of life (WHOQOL-HIV).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Endurance and Resistance Training Exercise
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Endurance ad Resistance Training Exercise
    Intervention Description
    Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week
    Primary Outcome Measure Information:
    Title
    Recruitment rate
    Description
    Number of eligible participants who enrolled in the program out of the number were recruited
    Time Frame
    At study completion (after 6 weeks)
    Title
    Retention rate
    Description
    Percentage of patients lost to follow-up
    Time Frame
    At study completion (after 6 weeks)
    Title
    Adverse events
    Description
    Percentage of patients who experienced one or more adverse events
    Time Frame
    At study completion (after 6 weeks)
    Secondary Outcome Measure Information:
    Title
    Weight
    Description
    Weight (kg) is measured by using a bioelectrical impedance analysis
    Time Frame
    Assessments at baseline and at 6 weeks
    Title
    Lean body mass
    Description
    Lean body mass (kg) is measured by using a bioelectrical impedance analysis
    Time Frame
    Assessments at baseline and at 6 weeks
    Title
    Fat body mass
    Description
    Lean body mass (kg) is measured by using a bioelectrical impedance analysis
    Time Frame
    Assessments at baseline and at 6 weeks
    Title
    C-reactive protein
    Description
    C-reactive protein is measured by a blood test
    Time Frame
    Assessments at baseline and at 12 weeks
    Title
    D-dimer
    Description
    D-dimer is measured by a blood test
    Time Frame
    Assessments at baseline and at 12 weeks
    Title
    CD4+ T cell counts
    Description
    CD4+ T cell counts is measured by a blood test
    Time Frame
    Assessments at baseline and at 12 weeks
    Title
    Viral load
    Description
    Viral load is measured by a blood test
    Time Frame
    Assessments at baseline and at 12 weeks
    Title
    Functional exercise capacity
    Description
    Functional exercise capacity is measured by a 6-minute walk test
    Time Frame
    Assessments at baseline and at 6 weeks
    Title
    Flexibility
    Description
    Flexibility is measured by Toe touch test and sit and reach test
    Time Frame
    Assessments at baseline and at 6 weeks
    Title
    Lower body muscular strength
    Description
    Lower body muscular strength is measured by 30-s chair-stand test
    Time Frame
    Assessments at baseline and at 6 weeks
    Title
    Upper limb strength
    Description
    Upper limb strength is measured by hand grip strength tool
    Time Frame
    Assessments at baseline and at 6 weeks
    Title
    Quality of life
    Description
    Quality of life is measured by World Health Organization Quality of Life HIV Instrument
    Time Frame
    Assessments at baseline and at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years or older under HAART treatment native French speaker Exclusion Criteria: AIDS diagnosis physical and/or psychiatric impairments that seriously impaired physical activity pregnant Unstable (defined by any modification of health outcomes during the last 6 months).

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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